Adocia super fast-acting insulin BC Lispro has positive clinical results
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Adocia super fast-acting insulin BC Lispro has positive clinical results.
Adocia retains the development rights of BC Lispro in the United States, Europe, Japan and Latin America, and is preparing for external licenses in these key areas.
On January 25, 2021, Adocia, dedicated to the treatment of diabetes and other metabolic diseases through innovative protein and peptide formulations, announced the positive results of a clinical study that compared BioChaperone using two different sources of insulin lispro ( BC) Lispro preparation, one is from Tonghua Dongbao (THDB) and the other is Humalog from Eli Lilly.
This randomized, crossover, double-blind, euglycemic clamp study was conducted in 30 patients with type 1 diabetes, and aimed to evaluate and compare the pharmacodynamics, pharmacokinetics, and safety of the following four preparations:
(1) BC Lispro (Adocia) composed of BioChaperone and Tonghua Dongbao insulin lispro;
(2) BC Lispro (Adocia) composed of BioChaperone and Humalog;
(3) Humalog approved in the United States;
(4) Humalog approved in Europe .
The results show that BC Lispro (THDB) has similar pharmacodynamic and pharmacokinetic characteristics to BC Lispro using Humalog.
Specifically, BC Lispro (THDB) showed a significantly faster absorption curve than Humalog’s two commercial formulations (Insulin lispro exposure AUClispro_0-1h in the first hour after injection: BC Lispro (THDB) was 550 pmol*h/ L, EU-Humalog is 379 pmol*h/L (p<0.0001vs BC Lispro (THDB)), US-Humalog is 366 pmol*h/L (p<0.0001 vs BC Lispro (THDB)); faster onset (The area under the glucose infusion rate curve in the first hour AUCGIR_0-1h: BC Lispro (THDB) is 200 mg/kg, EU-Humalog is 95 mg/kg (p=0.0027), US-Humalog is 83 mg/kg (p =0.0002)).
On the other hand, the late exposure and effect of BC Lispro (THDB) is lower than that of the two Humalog preparations (2-6 hours after administration of insulin lispro exposure AUClispro_2-6h: BC Lispro (THDB) is 802 pmol*h/L, EU -Humalog is 953 pmol*h/L (p <0.0001 vs BC Lispro (THDB)), US-Humalog is 1014 pmol*h/L (p <0.0001 vs BC Lispro (THDB); glucose infusion is 4-8h after administration Note the area under the rate curve AUCGIR_4-8h: BC Lispro (THDB) is 175 mg/kg, EU-Humalog is 268 mg/kg (p=0.0003 vsBC Lispro (THDB)), US-Humalog is 277 mg/kg (p=0.0001) vs BC Lispro (THDB)).
All four drugs are safe and well tolerated. These results confirm the super fast-acting insulin action characteristics of BC Lispro and the safety similar to Humalog. The study was approved by the FDA as part of the IND study on July 29, 2020.
BC Lispro is a super fast-acting pre-meal insulin preparation containing insulin lispro and proprietary BioChaperone technology. BioChaperone excipients can ensure faster absorption of insulin.
Adocia has designed the BioChaperone® platform technology using innovative polymers, oligomers and small molecular organic compounds.
By forming a complex with proteins, BioChaperone® can protect proteins from enzymatic degradation and improve performance.
BioChaperone® improves the efficacy of the “chaperone” protein by stabilizing and solubilizing: accelerate the onset of action and adjust the duration of action; enhance absorption and bioavailability; reduce the dosage and frequency of administration.
In 9 phase 1/2 clinical trials conducted in patients with type 1 and type 2 diabetes, administration via syringe or insulin pump compared with Eli Lilly’s insulin lispro Humalog and Novo Nordisk’s insulin aspart Novolog, BC Lispro works faster. In addition, in 6 clinical studies, BC Lispro significantly improved insulin performance compared with Humalog.
Adocia super fast-acting insulin: BC Lispro has positive clinical results
(source:internet, reference only)
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